4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide

EC Number:

259-571-1

EC Name:

4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide

Cas Number:

55290-62-5

Molecular formula:

C25H35N5O4S

IUPAC Name:

4-[(1-butyl-5-cyano-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazenyl]-N-(2-ethylhexyl)benzenesulfonamide

Details on test material:

- Physical state: yellow powder
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.51 to 2.93 kg
- Housing: individually in suspended metal cages
- Diet: Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (about 54 mg)

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72h

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72h

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72h

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48h

Irritant / corrosive response data:

Moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. Moderate conjunctival irritation was noted in one treated eye at the 24-hour observation with minimal conjunctiva! irritation at the 48-hour observation. Diffuse corneal opacity was noted in one treated eye at the 24-hour observation. No other corneal effects were noted. lridial inflammation was noted in one treated eye at the 1 and 24-hour observations. No other iridial effects were noted.

Other effects:

Yellow-coloured staining of the fur around the treated eye was noted in all animals throughout the study.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mild irritation responses were reported well below the threshold for classification.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced diffuse corneal opacity, iridial inflammation and moderate conjunctiva! irritation. No ocular effects were noted at the 72-hour observation. The test material produced a maximum group mean score of 11 .0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations.